When you become sick with a virus or are seeking information about a diet, where’s the first place that you turn to for help? Is it the doctor’s office or the internet? A recent study showed that the percentage of American adults that had access to the internet rose from 46% in 2000 to 74% in 2010. Another report showed that the internet (59%) was the most popular resource individuals used to seek health and wellness information, compared to 55% who sought the doctor, 29% who sought relatives, friends, or co-workers, and a meager 7% who sought disease associations and support groups (see Figure 1 below). These data show that we no longer live in a world in which the doctor is the primary giver of health information, but rather the internet has taken on this role and is slowly changing the face of medicine.
With the increasing interest in using the internet to seek health and wellness information, there has also been a corresponding boom in the popularity of using social media for the daily maintenance of health, including social networks, online communities, personal blogging, wikis, video-sharing, podcasts, and others. These technologies enable users to generate, change, and release content and are used by nearly all individuals in the health system. Patients and caregivers use social media to provide emotional support and clinical health information; clinicians and providers use it as a venue to share challenging cases and solutions; researchers use it to learn about side effects of medication regimes; large technology companies use social media as a business platform, and even federal agencies have begun to use it in initiatives, such as the Community Health Data Initiative between the Department of Health & Human Services (HHS) and the Institute of Medicine that is designed to promote public data availability and innovation.
One of the most valuable potential uses for social media in the field of clinical trials research is to increase patient recruitment. It is as a form of marketing that would cost little for the sponsoring company and could reach a broad audience who may have a great interest in the trial. In the 2010 white paper, “Using Social Media Platforms to Amplify Public Health Messages,” Alexandra Hughes outlines four tenets of strategic planning when using social media in healthcare. First, one must establish digital goals, strategies, and objectives. It is very easy to jump on the band wagon of using social media because it is popular. However, to be most effective, you should identify a purpose for using the social media and consider the benefits of using social media instead of other traditional forms of marketing. For instance, in clinical trials research, one objective may be to increase the number of patients enrolled in a clinical trial by 30%, and social media could potentially be chosen as the best tactic to use if the site of recruitment had an established network of social media platforms, such as a popular page on Facebook, like the Mayo Clinic.
Second, Hughes suggests segmenting and prioritizing your audience. Research has showed that different age groups, sexes, and races use social media differently. For instance, moms have been shown to use social media to track public health information for their children and ask other parents for advice, while seniors have used social media to socialize when they are not healthy enough to connect with their peers outside the home. Hughes shows that African Americans and Hispanics are more likely to use handheld mobile devices, such as the Smartphone, and Twitter, while Whites are more likely to search for information about prescription drugs and doctors online. Similarly, Hughes states that nurses are often more willing to engage in patient-to-provider social interactions using social media than physicians, and hospitals prefer to use the following in preferential order to recruit medical volunteers, convey important information, and align response efforts: Twitter, Facebook, YouTube, and blogs. When using social media to increase patient recruitment for a clinical trial, it is important to align the profile of patients to be recruited with the way in which they use the social media. For instance, a clinical trial recruiting children could be advertised on Facebook pages designed to attract moms, while a trial for a disease primarily affecting Hispanics could receive higher recruitment by using Twitter.
Third, Hughes recommends listening to the responses of others who have seen the social media. In other forms of advertising, such as the newspaper, information is sent out to the public and the newspaper company does not hear feedback on the articles directly. It can only use the number of papers sold and its profit margins as a metric of the articles it contains. In social media venues, such as Facebook, creators are able to receive feedback almost instantaneously. Hughes says that listening to this feedback can be critical in eliciting the desired response. In a clinical trial, this feedback may help to target problem areas in the protocol design, or to identify designs that were deemed successful and could be implemented in additional trials.
Fourth, Hughes emphasizes the importance of evaluating the use of the social media. Was it effective in achieving the objectives set forth for patient recruitment? Did it target the audience you had intended for the trial? How many followers, visitors, or fans did you receive on the media? If this venue did not aid in achieving your objectives, then other forms of marketing should be considered. Like all tactics, social media is one of many tools that can be used for marketing and patient recruitment in clinical trials.
In addition to these four tenets of planning, Hughes encourages social media venues to allow users to show their involvement in a visible way. The number of supporters of The Heart Truth campaign in 2008 increased 447% when individuals were given badges to post on their blog or social media profile. Similarly in clinical trials, giving supporters a way to show their involvement may create a greater sense of community and potentially lead to higher patient enrollment than expected.
As a contract research organization, Cato Research is highly interested and motivated in using any available tools to increase subject recruitment and retention in clinical trials for our sponsors, and we recognize that it is critical to understand the ethical and regulatory implications of the use of social media in the area of drug development. Institutional Review Boards (IRBs)/ethics boards and the FDA have very specific regulations regarding the direct advertisement of clinical trials, as it is considered to be the start of informed consent and subject selection. IRBs/ethics boards need to approve all advertisement and recruitment materials prior to their use, which could hinder the breadth and depth of clinical trial information made available to the public on social media platforms. At the same time, the purpose of receiving an IRBs approval is to ensure the information presented in an advertisement is easy to understand and accurate, which serves to protect individuals from deceptive allegations or from being coerced into participating in a trial for financial or other incentives. With the plethora of advertisements that currently exist in the sphere of social media, the function of IRBs and ethics boards in granting approval in this capacity reaches even greater importance.
While the FDA has issued a guidance on recruiting study subjects for IRBs and Clinical Investigators using traditional forms of media advertising, it has remained quiet on the use of social media for subject recruitment to date, with only promises of upcoming guidance on the use of the internet and social media for promotion of FDA-regulated medical products. The release of the FDA Draft Guidance on the Internet and Social Media, originally set for the end of 2010, has been pushed back to the first quarter of 2011 (the end of which is drawing near). The guidance is expected to contain information on how sponsors/investigators should incorporate links, respond to unsolicited requests, follow regulatory requirements when using tools associated with space limitations, fulfill post-marketing submission requirements, utilize on-line communications for manufacturers, packers, or distributors, and correct misinformation on the internet. As the popularity of social media rapidly spreads throughout the field of healthcare, all eyes turn to the FDA to await its guidance on how to navigate the complex and powerful waters of using social media for patient recruitment in clinical trials.
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